Safety and Immunogenicity of mRNAs Encoding HIV Immunogens (eOD-GT8 60mer, Core-g28v2 60mer, N332-GT5 gp151) in Adult Participants Without HIV and in Overall Good Health in South Africa (HVTN 317)

PHASE1Not yet recruitingINTERVENTIONAL
Enrollment

96

Participants

Timeline

Start Date

September 9, 2025

Primary Completion Date

December 19, 2025

Study Completion Date

December 19, 2025

Conditions
HIV Infections
Interventions
BIOLOGICAL

mRNA-1645-eODGT8

eOD-GT8 60mer is a self-assembling nanoparticle composed of 60 subunits of the engineered HIV-1 gp120 outer domain germline targeting version 8 (eOD-GT8) fused to an engineered form of a bacterial enzyme, Lumazine Synthase, through a 15-amino acid Glycine-Serine linker. eOD-GT8 60mer will be delivered using an mRNA lipid nanoparticle (LNP) platform. To be administered by intramuscular (IM) injection at doses of 10 or 30 mcg.

BIOLOGICAL

mRNA-1645-CoreG28v2

core-g28v2 60mer is a nanoparticle composed of 60 protein subunits of an engineered core-gp120 fused to an engineered form of a bacterial enzyme, Lumazine Synthase, through a 21-amino acid Glycine-Serine linker. Core-g28v2 60mer will be delivered using an mRNA-LNP platform. To be administered by IM injection at doses of 10 or 30 mcg.

BIOLOGICAL

mRNA-1645-N332GT5

"N332-GT5 gp151 is an HIV envelope glycoprotein gp151 trimer based on BG505 SOSIP MD39 (clade A) trimer with germline-targeting mutations added that confer the ability to bind germline precursors of BG18 class B cells. N332-GT5 gp151 will be delivered using an mRNA-LNP platform. To be administered by IM injection at doses of 10 or 30 mcg."

BIOLOGICAL

Placebo

Saline

Trial Locations (8)

1862

Soweto HVTN CRS, Soweto

2571

Klerksdorp CRS, Klerksdorp

4001

CAPRISA eThekwini CRS, Durban

4030

Chatsworth CRS, Chatsworth

4110

Isipingo CRS, Isipingo Rail

7750

Emavundleni CRS, Cape Town

7925

Groote Schuur HIV CRS, Cape Town

0152

Setshaba Research Centre CRS, Soshanguve

All Listed Sponsors
collaborator

National Institute of Allergy and Infectious Diseases (NIAID)

NIH

collaborator

ModernaTX, Inc.

INDUSTRY

collaborator

National Institutes of Health (NIH)

NIH

collaborator

Bill and Melinda Gates Foundation

OTHER

collaborator

United States Agency for International Development (USAID)

FED

collaborator

The Scripps Research Institute

OTHER

collaborator

International AIDS Vaccine Initiative

NETWORK

lead

HIV Vaccine Trials Network

NETWORK

NCT06694753 - Safety and Immunogenicity of mRNAs Encoding HIV Immunogens (eOD-GT8 60mer, Core-g28v2 60mer, N332-GT5 gp151) in Adult Participants Without HIV and in Overall Good Health in South Africa (HVTN 317) | Biotech Hunter | Biotech Hunter